Osteoporotic Vertebral Compression FracturesNCT07024095
Inspiratory Muscle Training After Vertebroplasty in Osteoporotic Fracture Patients
A study testing Inspiratory Muscle Training (IMT) in people with Osteoporotic Vertebral Compression Fractures and Restrictive Pulmonary Disorders, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the long-term effects of inspiratory muscle training (IMT) on pulmonary function, functional capacity, and quality of life in individuals with osteoporotic vertebral compression fractures who have undergone percutaneous vertebroplasty. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporotic Vertebral Compression Fractures, Restrictive Pulmonary Disorders, Inspiratory Muscle Weakness
- What is being tested?
- Inspiratory Muscle Training (IMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 50 years of age or older at the time of the study,
- Having a diagnosis of osteoporosis confirmed by a specialist physician,
- Having undergone percutaneous vertebroplasty surgery due to an osteoporotic vertebral compression fracture in the thoracic region within the past 3 months,
- Being cooperative with the questionnaires and assessment methods to be used in the study,
- Being able to read and voluntarily agree to participate in the study by signing the informed consent form.
Who cannot join
- Having a history of diagnosed unstable cardiac disease,
- Having a diagnosed pulmonary or neurological disorder,
- Having experienced an acute infection within the past 15 days,
- Being unable to participate in exercise interventions due to mental or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Neurosurgery, Kayseri State Hospital
Kayseri, Kocasinan, 38100
About this study
Official title: "Effects of Inspiratory Muscle Training on Pulmonary Function, Functional Capacity, and Quality of Life After Percutaneous Vertebroplasty in Individuals With Osteoporotic Vertebral Compression Fracture"
This study investigates the long-term effects of inspiratory muscle training (IMT) on pulmonary function, functional capacity, and quality of life in individuals with osteoporotic vertebral compression fractures who have undergone percutaneous vertebroplasty.
Participants aged 50 and older, diagnosed with osteoporosis and having undergone thoracic vertebroplasty within the past 3 months, will be randomly assigned to either an intervention group (IMT + standard rehabilitation) or a control group (standard rehabilitation only).
Read more
The primary outcome measure is spirometry-based pulmonary function. Secondary outcome measures include inspiratory muscle strength, functional walking capacity (6-minute walk test), diaphragmatic structure and elasticity, and quality of life (SGRQ, NHP).
This randomized controlled trial will be conducted at the Cardiopulmonary Rehabilitation Unit of Nuh Naci Yazgan University and aims to provide scientific evidence for integrating IMT into routine post-vertebroplasty rehabilitation protocols.
Read the detailed description
Vertebral compression fractures (VCFs) are among the most common complications of osteoporosis. In a Germany-based study, the annual incidence of VCFs in individuals aged 50 and above was reported as 307 per 100,000 people. The same study estimated the direct healthcare cost of VCFs to be approximately €6,490 within the first year after the fracture. The risk of VCF increases with age in both sexes, with a 40% rise in postmenopausal women. Although there is no specific epidemiological study on the incidence of VCFs in Turkey, a study conducted in 2025 reported an increased incidence of osteoporotic vertebral fractures due to limited access to healthcare and significantly reduced physical activity during the COVID-19 pandemic. Approximately one-third of osteoporotic VCFs are symptomatic and significantly reduce patients' quality of life. Whether symptomatic or asymptomatic, osteoporotic VCFs can lead to various health issues such as spinal deformities, nerve damage, functional limitations in thoracic and abdominal organs, reduced mobility, impaired pulmonary function, depression, and decreased quality of life. These fractures are also a major cause of acute and chronic back pain and are associated with increased risk of new fractures and mortality.
Percutaneous vertebroplasty (PV) is a minimally invasive procedure commonly used in the treatment of spinal pain caused by osteoporotic fractures, vertebral hemangiomas, and metastatic tumors. First performed by Deramond et al. in 1987 for spinal hemangiomas, PV has since been widely adopted as an effective treatment for osteoporotic and neoplastic vertebral fractures. During the procedure, under fluoroscopic or CT guidance, polymethyl methacrylate (PMMA) cement is injected into the fractured or weakened vertebral body through a specialized needle. Early studies reported significant pain reduction following the procedure with rare complications. Even before being fully supported by high-quality randomized controlled trials, PV was incorporated into clinical practice and became part of standard treatment for osteoporotic vertebral fractures. Cadaveric studies have also shown that vertebral body rigidity and mechanical strength are restored following PMMA injection.
Spinal pathologies such as vertebral fractures and deformities are known to cause restrictive pulmonary dysfunctions. Restrictive lung diseases encompass conditions characterized by reduced lung expansion capacity due to etiologies such as pulmonary fibrosis, neuromuscular diseases, and thoracic deformities. These conditions are associated with decreased total lung capacity (TLC), vital capacity (VC), and functional residual capacity (FRC), leading to impaired alveolar ventilation and increased respiratory muscle workload. Vertebral deformities, in particular, restrict chest wall mobility, preventing optimal function of respiratory muscles and reducing ventilatory capacity. The progressive nature of spinal deformities can reduce diaphragmatic mechanical efficiency and increase the work of breathing. Studies have shown a significant correlation between the degree of vertebral deformity and the degree of pulmonary dysfunction. A 2022 systematic review reported that increased Cobb angle in untreated idiopathic scoliosis is inversely related to forced vital capacity (FVC), VC, and TLC. Similarly, another study on adolescents who underwent thoracoplasty surgery for idiopathic scoliosis showed a significant postoperative decline in respiratory function.
Moreover, changes in respiratory function after PV are not solely due to pain reduction and mechanical improvements, but may also be influenced by physiological effects related to the surgery itself. Local tissue trauma during PV may affect the structural and functional integrity of paraspinal muscles in adjacent vertebral segments. This can result in inflammatory responses, spasms, or inhibition of paraspinal muscles, impairing spinal stability and indirectly limiting chest wall mobility. Additionally, protective breathing patterns due to postoperative pain may lead to dominant apical breathing instead of diaphragmatic breathing, causing inefficient respiratory muscle activity and reduced ventilation efficiency. Considering these physiological impacts, targeted inspiratory muscle training (IMT) in the postoperative period is viewed as a clinically important intervention to prevent or mitigate these adverse outcomes.
Although short-term improvements in pulmonary function following PV have been reported, there is no existing study that compares these improvements with healthy individuals. This creates uncertainty in determining the sufficiency and sustainability of post-PV functional gains relative to the pulmonary performance of the general population. Furthermore, most studies evaluating pulmonary function after PV provide limited long-term follow-up data, making it unclear whether the initial improvements are maintained or whether a decline occurs over time. IMT is thought to have the potential to support and enhance pulmonary function in the long term following PV. Studies have shown that IMT improves respiratory muscle strength, thoracic mobility, and dyspnea symptoms in patients undergoing thoracic surgery, and these effects are sustained in long-term follow-ups. Therefore, implementing IMT in patients after PV is clinically important to preserve the surgical gains, reduce pulmonary complications, and improve quality of life.
IMT is a well-established physiotherapeutic method proven effective following thoracic surgeries. It strengthens the respiratory muscles through resistance-based exercises, improving patients' respiratory capacity and functional recovery. Additionally, studies have shown that IMT can significantly improve balance, quality of life, and dyspnea. For example, a study investigating IMT in individuals with spinal cord injury found that six weeks of IMT significantly improved inspiratory muscle strength, quality of life, and pain compared to the placebo group. In another study by Kocjan et al., diaphragmatic thickness was evaluated via ultrasound following thoracic surgery, and a significant correlation between diaphragmatic thickness and balance levels was reported.
IMT has been shown to improve maximal inspiratory pressure and respiratory muscle endurance, thereby increasing exercise tolerance. Studies in patients with restrictive lung diseases also report that IMT enhances lung compliance and gas exchange efficiency, supporting ventilation-perfusion matching. In a study by Çalık et al., an 8-week IMT program in individuals with ankylosing spondylitis significantly improved respiratory muscle strength, functional exercise capacity, and Ankylosing Spondylitis Disease Activity Index scores. In another study evaluating paraplegic patients using wheelchairs following spinal cord injury, IMT led to significant improvements in aerobic capacity, respiratory muscle strength, and dyspnea compared to the control group.
Although the effects of respiratory muscle training on pulmonary function, muscle strength, quality of life, and balance have been studied in various restrictive pulmonary conditions, no study has evaluated its impact after PV. Therefore, this study aims to investigate the long-term effects of inspiratory muscle training on pulmonary function, inspiratory muscle strength, and quality of life in individuals who have undergone percutaneous vertebroplasty. It is anticipated that IMT may improve respiratory function by reducing dyspnea and enhance quality of life. Additionally, by reducing pulmonary complications, IMT may lead to decreased hospital admissions and lower healthcare costs. Given the limited literature evaluating the effects of IMT after PV, this study may provide a valuable contribution to the scientific literature and support the development of clinical rehabilitation protocols.
- Conditions
- Osteoporotic Vertebral Compression Fractures, Restrictive Pulmonary Disorders, Inspiratory Muscle Weakness, Postoperative Pulmonary Function
- Being tested
- Inspiratory Muscle Training (IMT), control group
- Keywords
- Vertebroplasty, Functional Capacity, Respiratory Muscle Training, Rehabilitation, Physical Fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training (IMT)Behavioural
Participants in the intervention group will receive, in addition to the standard postoperative follow-up for 8 weeks (3 days per week), a home-based exercise program including diaphragmatic breathing exercises, stretching exercises targeting kyphotic posture, and strengthening exercises for the thoracic region. These exercises will be taught to the patients and their caregivers by a licensed physiotherapist before hospital discharge.
In addition, inspiratory muscle training (IMT) will be performed every day for 8 weeks. To ensure progressive workload, maximal inspiratory pressure (MIP) will be reassessed weekly, and the IMT device will be adjusted accordingly.
control groupBehavioural
Participants in the control group will receive, similar to the intervention group, a home-based exercise program for 8 weeks (3 days per week), including diaphragmatic breathing exercises, stretching exercises for kyphotic posture, and strengthening exercises for the thoracic region, in addition to standard postoperative follow-up. These exercises will be demonstrated to the patients and their caregivers by a licensed physiotherapist before hospital discharge.
Unlike the intervention group, participants in this group will not receive inspiratory muscle training (IMT).
| Study group | Role | What they receive |
|---|---|---|
| İnspiratory traning group | Experimental | Participants in the intervention group will receive, in addition to the standard postoperative follow-up for 8 weeks (3 days per week), a home-based exercise program including diaphragmatic breathing exercises, stretching exercises targeting kyphotic posture, and strengthening exercises for the thoracic region. These exercises will be taught to the patients and their caregivers by a licensed physiotherapist before hospital discharge.
In addition, inspiratory muscle training (IMT) will be performed every day for 8 weeks. To ensure progressive workload, maximal inspiratory pressure (MIP) will be reassessed weekly, and the IMT device will be adjusted accordingly. Receives: Behavioral: Inspiratory Muscle Training (IMT) |
| Control Group | Active comparator | Participants in the control group will receive, similar to the intervention group, a home-based exercise program for 8 weeks (3 days per week), including diaphragmatic breathing exercises, stretching exercises for kyphotic posture, and strengthening exercises for the thoracic region, in addition to standard postoperative follow-up. These exercises will be demonstrated to the patients and their caregivers by a licensed physiotherapist before hospital discharge.
Unlike the intervention group, participants in this group will not receive inspiratory muscle training (IMT). Receives: Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Forced Vital Capacity - FVC
Forced vital capacity (FVC) will be assessed using a Cosmed Pony FX spirometer (Rome, Italy). All measurements will be conducted in accordance with the standards of the European Respiratory Society (ERS) and American Thoracic Society (ATS), with participants seated during the procedure. Each participant will perform at least three acceptable maneuvers, and the highest value will be recorded for analysis. FVC results will be expressed both in liters (L) as absolute values and as percentage of predicted values based on reference equations (Miller et al., 2005). In addition, the lower limit of normal (LLN) for FVC will be calculated (Hankinson et al., 1999).
Measured: Baseline, Week 4, and Week 8
Secondary outcomes (11)
Assessment Forced Expiratory Volume in 1 Second (FEV1)
FEV1 will be measured using the Cosmed Pony FX spirometer following ERS/ATS standardized procedures. Participants will be instructed to perform at least three acceptable maneuvers, and the highest FEV1 value will be used for analysis. Results will be presented as liters (L) and as percent of predicted values based on standardized reference equations. The lower limit of normal (LLN) for FEV1 will also be determined (Hankinson et al., 1999).
Measured: Baseline, week 4, week 8
Assessment FEV1/FVC Ratio
The FEV1/FVC ratio will be calculated using data obtained from spirometric testing with the Cosmed Pony FX spirometer. This parameter will be expressed as a percentage (%), and it will be used to assess the degree of airflow obstruction. Lower values of the FEV1/FVC ratio are indicative of obstructive respiratory patterns.
Measured: Baseline, week 4, week 8
Assessment Peak Expiratory Flow (PEF)
Peak expiratory flow (PEF) will be measured to determine the maximum speed of expiration. Measurements will be conducted using the Cosmed Pony FX spirometer in accordance with ERS/ATS guidelines. PEF values will be expressed in liters per second (L/s). Higher values reflect better expiratory performance.
Measured: Baseline, week 4, week 8
Assessment of Forced Expiratory Flow at 25-75% of Exhalation (FEF25-75)
FEF25-75 will be measured using the Cosmed Pony FX spirometer to assess mid-expiratory flow, which reflects small airway function. Participants will perform multiple spirometric maneuvers, and the highest acceptable value will be used in analysis. Results will be reported in liters per second (L/s).
Measured: Baseline, week 4, week 8
Assessment of Respiratory Muscle Strength
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) will be measured using an electronic mouth pressure device (Cosmed Pony FX Spirometer, Rome, Italy). MIP and MEP represent intraoral pressures generated against a closed valve and indirectly reflect respiratory muscle strength. For MIP, participants will exhale fully, then perform a maximal inspiratory effort against a closed valve for 1-3 seconds (Graham et al., 2019). For MEP, they will inhale fully and then exhale maximally for about 2 seconds against a closed valve (Miller et al., 2005). At least three acceptable attempts will be recorded for each measure, with a ≤5% difference between the two best values. The highest value will be used for analysis. Age- and sex-based interpretation will be done using reference equations developed by Black and Hyatt (1969).
Measured: Baseline, Week 4, and Week 8
Assessment of Diaphragm Muscle Thickness
To evaluate the morphological characteristics of the diaphragm muscle, high-resolution thoracic computed tomography (CT) images will be used. Images will be acquired using a Siemens CT scanner, and measurements will be taken from the crural region of the diaphragm in axial and coronal planes. Three measurements will be performed for both the right and left hemidiaphragm, and the average values will be recorded. Thickness will be measured from anatomical planes where the muscle borders are clearly defined. Symmetry, atrophy, and positional variations will also be evaluated. All images will be archived in the hospital's PACS system and analyzed by an experienced radiologist using standard anatomical landmarks to ensure reproducibility (Laghi et al., 2021). Diaphragm imaging will be performed during clinically indicated thoracic CT scans conducted as part of routine follow-up after percutaneous vertebroplasty. No additional imaging will be performed for research purposes.
Measured: Baseline and Week 8
Assessment of Diaphragm Muscle Elasticity
To assess the elastic properties of the diaphragm muscle, two-dimensional shear wave elastography (2D-SWE) will be used. Measurements will be performed using a Supersonic Imagine ultrasound device (Aixplorer, Provence, France) equipped with a high-frequency (4-15 MHz) linear probe. Participants will be positioned in the left lateral decubitus position, and the probe will be placed between the 6th and 12th intercostal spaces along the anterior to mid-axillary line to optimally visualize the right hemidiaphragm dome. Once an appropriate image is obtained, the elastography mode will be activated and the elasticity scale set to 0-160 kPa. Participants will be asked to hold their breath at the end of a calm full inspiration. Using the Q-BOX tool, three measurements of diaphragm stiffness will be taken within a 1 mm circular region of interest (ROI), and the mean value will be recorded (Chen et al., 2022).
Measured: Baseline and Week 8
Assessment of Functional Capacity
Functional capacity will be evaluated using the 6-Minute Walk Test (6MWT). Participants will be instructed to walk along a 30-meter flat corridor at the fastest pace they can maintain without running. Standardized verbal encouragement will be provided throughout the test to maintain participant motivation.
The assessment will be performed twice with a 30-minute interval, and the total distance covered during the second test will be recorded in meters (Enright, 2003). In addition, heart rate, blood pressure, respiratory rate, and oxygen saturation (measured using the Cosmed Spiropalm 6MWT, Rome, Italy) will be recorded before and after the test. Perceived dyspnea and fatigue levels during exertion will be assessed using the Modified Borg Scale (Borg, 1982).
Measured: Baseline, Week 4, and Week 8
Assessment of Quality of Life
Health-related quality of life of the individuals will be assessed using the St. George's Respiratory Questionnaire (SGRQ). This questionnaire consists of 76 items divided into three subscales: Symptoms (29 items), Activity (9 items), and Impacts (38 items). The Symptoms subscale evaluates respiratory complaints such as sputum production, coughing, and shortness of breath. The Activity subscale assesses limitations experienced during physical activities due to breathlessness, while the Impacts subscale examines the broader effects of the disease on daily life and psychosocial functioning. Each subscale, as well as the total score, ranges from 0 to 100, where 0 indicates no impairment in quality of life and 100 indicates severe impairment. The Turkish version of the questionnaire, which has been validated and shown to be reliable, will be used in this study.
Measured: Baseline, Week 4, and Week 8
Assessment of Quality of Life
Perceived health status of the individuals will be assessed using the Nottingham Health Profile (NHP). This questionnaire consists of six subscales: pain, emotional reactions, social isolation, sleep, energy level, and physical mobility. Each subscale evaluates the extent to which the individual is affected in that specific domain of health. Scores for each subscale range from 0 to 100, with higher scores indicating greater negative impact on the individual's health status. The validated and reliable Turkish version of the questionnaire will be used in this study.
Measured: Baseline, Week 4, and Week 8
Assessment of Kinesiophobia
Fear of movement due to pain among study participants will be assessed using the Tampa Scale for Kinesiophobia (TSK). The TSK is a self-report questionnaire designed to evaluate individuals' fear and avoidance behaviors related to physical activity.
The scale consists of 17 items, each rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). Total scores range from 17 to 68, with higher scores indicating greater levels of kinesiophobia.
In this study, the Turkish version of the TSK, which has been validated for reliability and cultural relevance, will be used (Yılmaz et al., 2011).
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jul 2025
- Primary completion22 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Osteoporotic Vertebral Compression FracturesStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups using stratified randomization based on potential confounding variables such as age and sex: * The intervention group will receive inspiratory muscle training (IMT) in addition to standard postoperative rehabilitation. * The control group will receive only standard postoperative rehabilitation. Randomization will be performed using a computer-generated stratified sequence, and group allocation will be concealed. The interventions will be conducted in parallel over a period of 8 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024095
- Sponsor's protocol ID
- ISTÜ-IMT-001
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao H, He Y, Yang JS, Bao W, Chen J, Liu JJ, Li QD, Liu P, Qian B, Zhao YT, Hao DJ. Can paraspinal muscle degeneration be a reason for refractures after percutaneous kyphoplasty? A magnetic resonance imaging observation. J Orthop Surg Res. 2021 Aug 3;16(1):476. doi: 10.1186/s13018-021-02623-y.
PubMed 34344407Wang B, Zhao CP, Song LX, Zhu L. Balloon kyphoplasty versus percutaneous vertebroplasty for osteoporotic vertebral compression fracture: a meta-analysis and systematic review. J Orthop Surg Res. 2018 Oct 22;13(1):264. doi: 10.1186/s13018-018-0952-5.
PubMed 30348192Vasold KL, Parks AC, Phelan DML, Pontifex MB, Pivarnik JM. Reliability and Validity of Commercially Available Low-Cost Bioelectrical Impedance Analysis. Int J Sport Nutr Exerc Metab. 2019 Jul 1;29(4):406-410. doi: 10.1123/ijsnem.2018-0283.
PubMed 30507268Tomas-Carus P, Biehl-Printes C, Del Pozo-Cruz J, Parraca JA, Folgado H, Perez-Sousa MA. Effects of respiratory muscle training on respiratory efficiency and health-related quality of life in sedentary women with fibromyalgia: a randomised controlled trial. Clin Exp Rheumatol. 2022 Jun;40(6):1119-1126. doi: 10.55563/clinexprheumatol/0v55nh. Epub 2022 Jun 22.
PubMed 35748715Soumyashree S, Kaur J. Effect of inspiratory muscle training (IMT) on aerobic capacity, respiratory muscle strength and rate of perceived exertion in paraplegics. J Spinal Cord Med. 2020 Jan;43(1):53-59. doi: 10.1080/10790268.2018.1462618. Epub 2018 Apr 18.
PubMed 29667507Robinson HC. Respiratory Conditions Update: Restrictive Lung Disease. FP Essent. 2016 Sep;448:29-34.
PubMed 27576233Polatli M, Yorgancioglu A, Aydemir O, Yilmaz Demirci N, Kirkil G, Atis Nayci S, Kokturk N, Uysal A, Akdemir SE, Ozgur ES, Gunakan G. [Validity and reliability of Turkish version of St. George's respiratory questionnaire]. Tuberk Toraks. 2013;61(2):81-7. doi: 10.5578/tt.5404. Turkish.
PubMed 23875584Pazzianotto-Forti EM, da Costa Munno CM, Merino DFB, Simoes da Rocha MR, de Mori TA, Junior IR. Effects of Inspiratory Exercise With Linear and Nonlinear Load on Respiratory Variables Post-Bariatric Surgery. Respir Care. 2019 Dec;64(12):1516-1522. doi: 10.4187/respcare.05841. Epub 2019 Aug 6.
PubMed 31387894Palermo AE, Cahalin LP, Nash MS. A case for inspiratory muscle training in SCI: potential role as a preventative tool in infectious respiratory diseases like COVID-19. Spinal Cord Ser Cases. 2020 Sep 17;6(1):87. doi: 10.1038/s41394-020-00337-7.
PubMed 32943611Noonan AM, Brown SHM. Paraspinal muscle pathophysiology associated with low back pain and spine degenerative disorders. JOR Spine. 2021 Sep 15;4(3):e1171. doi: 10.1002/jsp2.1171. eCollection 2021 Sep.
PubMed 34611593Newall C, Stockley RA, Hill SL. Exercise training and inspiratory muscle training in patients with bronchiectasis. Thorax. 2005 Nov;60(11):943-8. doi: 10.1136/thx.2004.028928. Epub 2005 Jun 30.
PubMed 15994254Mills DE, Johnson MA, Barnett YA, Smith WH, Sharpe GR. The effects of inspiratory muscle training in older adults. Med Sci Sports Exerc. 2015 Apr;47(4):691-7. doi: 10.1249/MSS.0000000000000474.
PubMed 25116085Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.
PubMed 15994402Messaggi-Sartor M, Marco E, Martinez-Tellez E, Rodriguez-Fuster A, Palomares C, Chiarella S, Muniesa JM, Orozco-Levi M, Barreiro E, Guell MR. Combined aerobic exercise and high-intensity respiratory muscle training in patients surgically treated for non-small cell lung cancer: a pilot randomized clinical trial. Eur J Phys Rehabil Med. 2019 Feb;55(1):113-122. doi: 10.23736/S1973-9087.18.05156-0. Epub 2018 Jul 6.
PubMed 29984565Liu JF, Kuo NY, Fang TP, Chen JO, Lu HI, Lin HL. A six-week inspiratory muscle training and aerobic exercise improves respiratory muscle strength and exercise capacity in lung cancer patients after video-assisted thoracoscopic surgery: A randomized controlled trial. Clin Rehabil. 2021 Jun;35(6):840-850. doi: 10.1177/0269215520980138. Epub 2020 Dec 14.
PubMed 33307766
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effects of Inspiratory Muscle Training on Pulmonary Function, Functional Capacity, and Quality of Life After Percutaneous Vertebroplasty in Individuals With Osteoporotic Vertebral Compression Fracture"
- ClinicalTrials.gov ID
- NCT07024095
- Acronym / sponsor ID
- ISTÜ-IMT-001
- Conditions
- Osteoporotic Vertebral Compression Fractures, Restrictive Pulmonary Disorders, Inspiratory Muscle Weakness, Postoperative Pulmonary Function
- Keywords
- Vertebroplasty, Functional Capacity, Respiratory Muscle Training, Rehabilitation, Physical Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the long-term effects of inspiratory muscle training (IMT) on pulmonary function, functional capacity, and quality of life in individuals with osteoporotic vertebral compression fractures who have undergone percutaneous vertebroplasty.
Participants aged 50 and older, diagnosed with osteoporosis and having undergone thoracic vertebroplasty within the past 3 months, will be randomly assigned to either an intervention group (IMT + standard rehabilitation) or a control group (standard rehabilitation only).
The primary outcome measure is spirometry-based pulmonary function. Secondary outcome measures include inspiratory muscle strength, functional walking capacity (6-minute walk test), diaphragmatic structure and elasticity, and quality of life (SGRQ, NHP).
This randomized controlled trial will be conducted at the Cardiopulmonary Rehabilitation Unit of Nuh Naci Yazgan University and aims to provide scientific evidence for integrating IMT into routine post-vertebroplasty rehabilitation protocols.
Detailed description
Vertebral compression fractures (VCFs) are among the most common complications of osteoporosis. In a Germany-based study, the annual incidence of VCFs in individuals aged 50 and above was reported as 307 per 100,000 people. The same study estimated the direct healthcare cost of VCFs to be approximately €6,490 within the first year after the fracture. The risk of VCF increases with age in both sexes, with a 40% rise in postmenopausal women. Although there is no specific epidemiological study on the incidence of VCFs in Turkey, a study conducted in 2025 reported an increased incidence of osteoporotic vertebral fractures due to limited access to healthcare and significantly reduced physical activity during the COVID-19 pandemic. Approximately one-third of osteoporotic VCFs are symptomatic and significantly reduce patients' quality of life. Whether symptomatic or asymptomatic, osteoporotic VCFs can lead to various health issues such as spinal deformities, nerve damage, functional limitations in thoracic and abdominal organs, reduced mobility, impaired pulmonary function, depression, and decreased quality of life. These fractures are also a major cause of acute and chronic back pain and are associated with increased risk of new fractures and mortality.
Percutaneous vertebroplasty (PV) is a minimally invasive procedure commonly used in the treatment of spinal pain caused by osteoporotic fractures, vertebral hemangiomas, and metastatic tumors. First performed by Deramond et al. in 1987 for spinal hemangiomas, PV has since been widely adopted as an effective treatment for osteoporotic and neoplastic vertebral fractures. During the procedure, under fluoroscopic or CT guidance, polymethyl methacrylate (PMMA) cement is injected into the fractured or weakened vertebral body through a specialized needle. Early studies reported significant pain reduction following the procedure with rare complications. Even before being fully supported by high-quality randomized controlled trials, PV was incorporated into clinical practice and became part of standard treatment for osteoporotic vertebral fractures. Cadaveric studies have also shown that vertebral body rigidity and mechanical strength are restored following PMMA injection.
Spinal pathologies such as vertebral fractures and deformities are known to cause restrictive pulmonary dysfunctions. Restrictive lung diseases encompass conditions characterized by reduced lung expansion capacity due to etiologies such as pulmonary fibrosis, neuromuscular diseases, and thoracic deformities. These conditions are associated with decreased total lung capacity (TLC), vital capacity (VC), and functional residual capacity (FRC), leading to impaired alveolar ventilation and increased respiratory muscle workload. Vertebral deformities, in particular, restrict chest wall mobility, preventing optimal function of respiratory muscles and reducing ventilatory capacity. The progressive nature of spinal deformities can reduce diaphragmatic mechanical efficiency and increase the work of breathing. Studies have shown a significant correlation between the degree of vertebral deformity and the degree of pulmonary dysfunction. A 2022 systematic review reported that increased Cobb angle in untreated idiopathic scoliosis is inversely related to forced vital capacity (FVC), VC, and TLC. Similarly, another study on adolescents who underwent thoracoplasty surgery for idiopathic scoliosis showed a significant postoperative decline in respiratory function.
Moreover, changes in respiratory function after PV are not solely due to pain reduction and mechanical improvements, but may also be influenced by physiological effects related to the surgery itself. Local tissue trauma during PV may affect the structural and functional integrity of paraspinal muscles in adjacent vertebral segments. This can result in inflammatory responses, spasms, or inhibition of paraspinal muscles, impairing spinal stability and indirectly limiting chest wall mobility. Additionally, protective breathing patterns due to postoperative pain may lead to dominant apical breathing instead of diaphragmatic breathing, causing inefficient respiratory muscle activity and reduced ventilation efficiency. Considering these physiological impacts, targeted inspiratory muscle training (IMT) in the postoperative period is viewed as a clinically important intervention to prevent or mitigate these adverse outcomes.
Although short-term improvements in pulmonary function following PV have been reported, there is no existing study that compares these improvements with healthy individuals. This creates uncertainty in determining the sufficiency and sustainability of post-PV functional gains relative to the pulmonary performance of the general population. Furthermore, most studies evaluating pulmonary function after PV provide limited long-term follow-up data, making it unclear whether the initial improvements are maintained or whether a decline occurs over time. IMT is thought to have the potential to support and enhance pulmonary function in the long term following PV. Studies have shown that IMT improves respiratory muscle strength, thoracic mobility, and dyspnea symptoms in patients undergoing thoracic surgery, and these effects are sustained in long-term follow-ups. Therefore, implementing IMT in patients after PV is clinically important to preserve the surgical gains, reduce pulmonary complications, and improve quality of life.
IMT is a well-established physiotherapeutic method proven effective following thoracic surgeries. It strengthens the respiratory muscles through resistance-based exercises, improving patients' respiratory capacity and functional recovery. Additionally, studies have shown that IMT can significantly improve balance, quality of life, and dyspnea. For example, a study investigating IMT in individuals with spinal cord injury found that six weeks of IMT significantly improved inspiratory muscle strength, quality of life, and pain compared to the placebo group. In another study by Kocjan et al., diaphragmatic thickness was evaluated via ultrasound following thoracic surgery, and a significant correlation between diaphragmatic thickness and balance levels was reported.
IMT has been shown to improve maximal inspiratory pressure and respiratory muscle endurance, thereby increasing exercise tolerance. Studies in patients with restrictive lung diseases also report that IMT enhances lung compliance and gas exchange efficiency, supporting ventilation-perfusion matching. In a study by Çalık et al., an 8-week IMT program in individuals with ankylosing spondylitis significantly improved respiratory muscle strength, functional exercise capacity, and Ankylosing Spondylitis Disease Activity Index scores. In another study evaluating paraplegic patients using wheelchairs following spinal cord injury, IMT led to significant improvements in aerobic capacity, respiratory muscle strength, and dyspnea compared to the control group.
Although the effects of respiratory muscle training on pulmonary function, muscle strength, quality of life, and balance have been studied in various restrictive pulmonary conditions, no study has evaluated its impact after PV. Therefore, this study aims to investigate the long-term effects of inspiratory muscle training on pulmonary function, inspiratory muscle strength, and quality of life in individuals who have undergone percutaneous vertebroplasty. It is anticipated that IMT may improve respiratory function by reducing dyspnea and enhance quality of life. Additionally, by reducing pulmonary complications, IMT may lead to decreased hospital admissions and lower healthcare costs. Given the limited literature evaluating the effects of IMT after PV, this study may provide a valuable contribution to the scientific literature and support the development of clinical rehabilitation protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups using stratified randomization based on potential confounding variables such as age and sex: * The intervention group will receive inspiratory muscle training (IMT) in addition to standard postoperative rehabilitation. * The control group will receive only standard postoperative rehabilitation. Randomization will be performed using a computer-generated stratified sequence, and group allocation will be concealed. The interventions will be conducted in parallel over a period of 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| İnspiratory traning group | Experimental | Behavioral: Inspiratory Muscle Training (IMT)Participants in the intervention group will receive, in addition to the standard postoperative follow-up for 8 weeks (3 days per week), a home-based exercise program including diaphragmatic breathing exercises, stretching exercises targeting kyphotic posture, and strengthening exercises for the thoracic region. These exercises will be taught to the patients and their caregivers by a licensed physiotherapist before hospital discharge. In addition, inspiratory muscle training (IMT) will be performed every day for 8 weeks. To ensure progressive workload, maximal inspiratory pressure (MIP) will be reassessed weekly, and the IMT device will be adjusted accordingly. |
| Control Group | Active comparator | Behavioral: control groupParticipants in the control group will receive, similar to the intervention group, a home-based exercise program for 8 weeks (3 days per week), including diaphragmatic breathing exercises, stretching exercises for kyphotic posture, and strengthening exercises for the thoracic region, in addition to standard postoperative follow-up. These exercises will be demonstrated to the patients and their caregivers by a licensed physiotherapist before hospital discharge. Unlike the intervention group, participants in this group will not receive inspiratory muscle training (IMT). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being 50 years of age or older at the time of the study,
- Having a diagnosis of osteoporosis confirmed by a specialist physician,
- Having undergone percutaneous vertebroplasty surgery due to an osteoporotic vertebral compression fracture in the thoracic region within the past 3 months,
- Being cooperative with the questionnaires and assessment methods to be used in the study,
- Being able to read and voluntarily agree to participate in the study by signing the informed consent form.
Key exclusion criteria (4 listed)
- Having a history of diagnosed unstable cardiac disease,
- Having a diagnosed pulmonary or neurological disorder,
- Having experienced an acute infection within the past 15 days,
- Being unable to participate in exercise interventions due to mental or cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle Training (IMT)Participants in the intervention group will receive, in addition to the standard postoperative follow-up for 8 weeks (3 days per week), a home-based exercise program including diaphragmatic breathing exercises, stretching exercises targeting kyphotic posture, and strengthening exercises for the thoracic region. These exercises will be taught to the patients and their caregivers by a licensed physiotherapist before hospital discharge. In addition, inspiratory muscle training (IMT) will be performed every day for 8 weeks. To ensure progressive workload, maximal inspiratory pressure (MIP) will be reassessed weekly, and the IMT device will be adjusted accordingly. | Behavioural | İnspiratory traning group |
| control groupParticipants in the control group will receive, similar to the intervention group, a home-based exercise program for 8 weeks (3 days per week), including diaphragmatic breathing exercises, stretching exercises for kyphotic posture, and strengthening exercises for the thoracic region, in addition to standard postoperative follow-up. These exercises will be demonstrated to the patients and their caregivers by a licensed physiotherapist before hospital discharge. Unlike the intervention group, participants in this group will not receive inspiratory muscle training (IMT). | Behavioural | Control Group |
Primary outcome
Assessment of Forced Vital Capacity - FVC
Time frame: Baseline, Week 4, and Week 8
Forced vital capacity (FVC) will be assessed using a Cosmed Pony FX spirometer (Rome, Italy). All measurements will be conducted in accordance with the standards of the European Respiratory Society (ERS) and American Thoracic Society (ATS), with participants seated during the procedure. Each participant will perform at least three acceptable maneuvers, and the highest value will be recorded for analysis. FVC results will be expressed both in liters (L) as absolute values and as percentage of predicted values based on reference equations (Miller et al., 2005). In addition, the lower limit of normal (LLN) for FVC will be calculated (Hankinson et al., 1999).
11 secondary outcomes
Assessment Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, week 4, week 8
Assessment FEV1/FVC Ratio
Time frame: Baseline, week 4, week 8
Assessment Peak Expiratory Flow (PEF)
Time frame: Baseline, week 4, week 8
Assessment of Forced Expiratory Flow at 25-75% of Exhalation (FEF25-75)
Time frame: Baseline, week 4, week 8
Assessment of Respiratory Muscle Strength
Time frame: Baseline, Week 4, and Week 8
Assessment of Diaphragm Muscle Thickness
Time frame: Baseline and Week 8
Assessment of Diaphragm Muscle Elasticity
Time frame: Baseline and Week 8
Assessment of Functional Capacity
Time frame: Baseline, Week 4, and Week 8
Assessment of Quality of Life
Time frame: Baseline, Week 4, and Week 8
Assessment of Quality of Life
Time frame: Baseline, Week 4, and Week 8
Assessment of Kinesiophobia
Time frame: Baseline, Week 4, and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 34344407Zhao H, He Y, Yang JS, Bao W, Chen J, Liu JJ, Li QD, Liu P, Qian B, Zhao YT, Hao DJ. Can paraspinal muscle degeneration be a reason for refractures after percutaneous kyphoplasty? A magnetic resonance imaging observation. J Orthop Surg Res. 2021 Aug 3;16(1):476. doi: 10.1186/s13018-021-02623-y.
- Background: PubMed 30348192Wang B, Zhao CP, Song LX, Zhu L. Balloon kyphoplasty versus percutaneous vertebroplasty for osteoporotic vertebral compression fracture: a meta-analysis and systematic review. J Orthop Surg Res. 2018 Oct 22;13(1):264. doi: 10.1186/s13018-018-0952-5.
- Background: PubMed 30507268Vasold KL, Parks AC, Phelan DML, Pontifex MB, Pivarnik JM. Reliability and Validity of Commercially Available Low-Cost Bioelectrical Impedance Analysis. Int J Sport Nutr Exerc Metab. 2019 Jul 1;29(4):406-410. doi: 10.1123/ijsnem.2018-0283.
- Background: PubMed 35748715Tomas-Carus P, Biehl-Printes C, Del Pozo-Cruz J, Parraca JA, Folgado H, Perez-Sousa MA. Effects of respiratory muscle training on respiratory efficiency and health-related quality of life in sedentary women with fibromyalgia: a randomised controlled trial. Clin Exp Rheumatol. 2022 Jun;40(6):1119-1126. doi: 10.55563/clinexprheumatol/0v55nh. Epub 2022 Jun 22.
- Background: PubMed 29667507Soumyashree S, Kaur J. Effect of inspiratory muscle training (IMT) on aerobic capacity, respiratory muscle strength and rate of perceived exertion in paraplegics. J Spinal Cord Med. 2020 Jan;43(1):53-59. doi: 10.1080/10790268.2018.1462618. Epub 2018 Apr 18.
- Background: PubMed 27576233Robinson HC. Respiratory Conditions Update: Restrictive Lung Disease. FP Essent. 2016 Sep;448:29-34.
- Background: PubMed 23875584Polatli M, Yorgancioglu A, Aydemir O, Yilmaz Demirci N, Kirkil G, Atis Nayci S, Kokturk N, Uysal A, Akdemir SE, Ozgur ES, Gunakan G. [Validity and reliability of Turkish version of St. George's respiratory questionnaire]. Tuberk Toraks. 2013;61(2):81-7. doi: 10.5578/tt.5404. Turkish.
- Background: PubMed 31387894Pazzianotto-Forti EM, da Costa Munno CM, Merino DFB, Simoes da Rocha MR, de Mori TA, Junior IR. Effects of Inspiratory Exercise With Linear and Nonlinear Load on Respiratory Variables Post-Bariatric Surgery. Respir Care. 2019 Dec;64(12):1516-1522. doi: 10.4187/respcare.05841. Epub 2019 Aug 6.
- Background: PubMed 32943611Palermo AE, Cahalin LP, Nash MS. A case for inspiratory muscle training in SCI: potential role as a preventative tool in infectious respiratory diseases like COVID-19. Spinal Cord Ser Cases. 2020 Sep 17;6(1):87. doi: 10.1038/s41394-020-00337-7.
- Background: PubMed 34611593Noonan AM, Brown SHM. Paraspinal muscle pathophysiology associated with low back pain and spine degenerative disorders. JOR Spine. 2021 Sep 15;4(3):e1171. doi: 10.1002/jsp2.1171. eCollection 2021 Sep.
- Background: PubMed 15994254Newall C, Stockley RA, Hill SL. Exercise training and inspiratory muscle training in patients with bronchiectasis. Thorax. 2005 Nov;60(11):943-8. doi: 10.1136/thx.2004.028928. Epub 2005 Jun 30.
- Background: PubMed 25116085Mills DE, Johnson MA, Barnett YA, Smith WH, Sharpe GR. The effects of inspiratory muscle training in older adults. Med Sci Sports Exerc. 2015 Apr;47(4):691-7. doi: 10.1249/MSS.0000000000000474.
- Individual participant dataSharing planned: No
Related trials for Osteoporotic Vertebral Compression Fractures
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Recruiting
Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System
Osteoporosis, Osteoporotic Vertebral Compression Fractures
Recruiting
Development and Application of a Clinical Decision Support System for Exercise Rehabilitation in Patients With Osteoporotic Vertebral Compression Fractures
Clinical Decision Support System
Recruiting
Standardized Study Protocol of Percutaneous Vertebroplasty Based on Pedicle Nine-Grid Zoning Method
Osteoporotic Vertebral Compression Fractures, Vertebroplasty
Not yet recruiting
RCT on the Efficacy and Safety of Minimally Invasive SAIF Technique vs Spinal Fixation in Unstable Osteoporotic Vertebral Fractures
Unstable Osteoporotic Vertebral Compression Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training (IMT) in people with Osteoporotic Vertebral Compression Fractures and Restrictive Pulmonary Disorders, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Forced Vital Capacity - FVC (time frame: Baseline, Week 4, and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07024095, which also lists 43 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.